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Norepinephrine Reuptake Inhibitor

Ampreloxetine for Multiple System Atrophy (CYPRESS Trial)

Phase 3

Recruiting

Research Sponsored by Theravance Biopharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must score at least a 4 on the OHSA item 1 at Visit 2 (Day 1).

Participant must meet the diagnostic criteria of nOH, as demonstrated by a sustained reduction in BP of ≥20 mmHg (systolic) or ≥10 mmHg (diastolic) within 3 min of standing as part of orthostatic standing test or being tilted up ≥60o from a supine position as determined by a tilt-table test.

Must not have

Major surgery (i.e., procedures involving higher risk for infection and extended recovery period, such as, joint replacement, gastric bypass, open heart surgery, organ transplant, etc.) occurring less than 4 weeks prior to enrollment.

Participant has known congestive heart failure (New York Heart Association [NYHA] Class 3 or 4).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-week randomized withdrawal period (week 12 to week 20)

Awards & highlights

Pivotal Trial

Summary

This trial studies how well a drug helps treat Multiple System Atrophy with a form of dizziness. It has 4 steps and lasts 20 weeks.

Who is the study for?

Adults over 30 with Multiple System Atrophy (MSA) and symptomatic neurogenic orthostatic hypotension (nOH), confirmed by specific criteria. Participants must not be pregnant, agree to use effective birth control, and cannot have certain cardiovascular conditions or recent substance abuse. Those on certain medications for nOH or with severe cognitive impairment are excluded.

What is being tested?

The trial is testing Ampreloxetine's effectiveness in treating low blood pressure due to MSA compared to a placebo. It includes an initial open label phase where everyone gets the drug, followed by a randomized withdrawal period to see if benefits last without it, and then long-term treatment.

What are the potential side effects?

While the side effects of Ampreloxetine aren't detailed here, similar drugs can cause headaches, dizziness upon standing (due to blood pressure changes), digestive issues like constipation or diarrhea, heart rate changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I scored at least a 4 on a specific health assessment.

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My blood pressure drops significantly when I stand up.

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I am at least 30 years old.

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I have been diagnosed with MSA, either Parkinsonian or cerebellar type.

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I have been diagnosed with MSA, either Parkinsonian or cerebellar type.

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I have been diagnosed with MSA, either Parkinsonian or cerebellar type.

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I have been diagnosed with MSA, either Parkinsonian or cerebellar type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 4 weeks.

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I have severe heart failure (NYHA Class 3 or 4).

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I have not had a heart attack or unstable heart disease in the last 6 months.

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I have not taken any MAOI drugs in the last 14 days.

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I am allergic or have had bad reactions to certain depression medications.

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I have abnormal blood tests that could affect my safety in the trial.

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I have experienced a new neurological issue, like seizures or confusion, in the last 6 months.

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I haven't had any cancer, except for cervical carcinoma in situ or basal cell carcinoma, in the last 2 years.

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I am not currently on, nor have I taken any experimental drugs in the last 30 days.

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I have serious heart rhythm problems or a long QT interval.

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I am willing and able to follow all study requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-week randomized withdrawal period (week 12 to week 20)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-week randomized withdrawal period (week 12 to week 20)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-week randomized withdrawal period (week 12 to week 20) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in OHSA composite score at Week 8 during the double-blind RW period

Secondary study objectives

Change from baseline in OHDAS item 1 (activities that require standing for a short time) at Week 8 post randomization

Change from baseline in OHDAS item 3 (activities that require walking for a short time) at Week 8 post randomization

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Ampreloxetine (Open Label)Active Control1 Intervention

Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 12 weeks.

Group II: Long-Term Extension PeriodActive Control1 Intervention

Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 104 weeks.

Group III: Ampreloxetine (Randomized Withdrawal)Placebo Group2 Interventions

After completing the open label, participants are randomized to either ampreloxetine or placebo receiving a single, oral, daily dose of active drug or placebo for a further 8 weeks.

0 / 18Eligibility criteria met